BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE SPOT LIGHT

    MDR report key: 584100 · Received March 18, 2005

    Report

    Report Number
    1121732-2005-00003
    Event Type
    Injury
    Date Received
    March 18, 2005
    Date of Event
    February 20, 2005
    Report Date
    March 17, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    LBI
    Removal / Correction Number
    Z-0160-6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT WAS BURNED DURING PHOTOTHERAPY WITH THE GIRAFFE SPOT PT LIGHT. CUSTOMER REPORTED THEY HAD THE LIGHT POSITIONED APPROX 6" FROM THE PT. INVESTIGATION/CONCLUSION: THE USER MANUAL WARNS THE USER THAT THE LIGHT SHOULD BE POSITIONED NO CLOSER THAN 15" FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE SPOT LIGHT PHOTOTHERAPY LBI OHMEDA MEDICAL GIRAFFE SPOT PT LIGHT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention